[Notice] Celltrion Online Conference Video Now Available

We are pleased to share the link of the English-subtitled video clip of the <Celltrion Online Conference>, held on Tuesday, September 23, 2025 for international viewers.


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Letter to Shareholders [Notice Regarding the Acquisition of Eli Lilly’ U.S. Manufacturing Facility]

Dear Shareholders,

 

On July 29, we informed you that we had been selected as the preferred bidder for the acquisition of a biologics manufacturing facility in the United States. As of September 20 (local time), we have successfully signed an agreement with Eli Lilly to acquire this facility. We are pleased to share the details with you promptly, as outlined below.

 

1. Overview of the Acquisition

  • Facility to be Acquired: A biopharmaceutical drug substance (DS) plant in Branchburg, New Jersey, owned by global pharmaceutical leader Eli Lilly. The site covers approximately 37 acres, including four buildings (with 10 acres of vacant land available for future use)
  • Acquisition Value: Approximately KRW 460 billion (about KRW 700 billion including operational funds)
  • Acquiring Entity: Celltrion U.S. subsidiary (chosen for operational efficiency and legal stability)

 

2. Completion of Comprehensive U.S. Tariff Response Plan

  • Recently Celltrion has proactively addressed tariff-related risks by transferring two years’ worth of inventory to the U.S. and expanding contracts with local CMO partners, implementing stage-specific measures to mitigate exposure
  • Following validation of the newly acquired facility (estimated 12–18 months), Celltrion products will be manufactured and supplied directly from this site
  • With this acquisition, Celltrion has fundamentally and fully eliminated all potential future tariff risks related to its products in the U.S. market

 

3. Additional Benefits of the Acquisition

  • Immediate Utilization: By acquiring an existing facility rather than constructing a new one, Celltrion achieves significant cost savings and can commence operations immediately. Full employee retention ensures continuity of production and access to skilled expertise, while ongoing CMO contracts provide immediate revenue streams and accelerate recovery of invested capital

 

  • Reduction in External CMO and Logistics Costs: The facility enables full-cycle integration — from drug substance production through finished product manufacturing, packaging, logistics, and sales — within the U.S., thereby strengthening operational capacity. Localized production will also reduce logistics costs previously incurred for U.S.-bound shipments, as well as lower external CMO-related expenses

 

4. Next Steps

  • Preparations are underway to transfer operations and complete closing procedures by year-end
  • During this period, Celltrion will proceed with required regulatory approvals, including U.S. merger control filings, and expects to finalize the transaction by the end of this year

 

As the acquisition process moves forward, we remain committed to keeping our shareholders fully informed of any updates in a timely manner, ensuring continued trust and support for Celltrion. 

 

Thank you.

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News

FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States

YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S. [1] , [2]Pediatric UV is a rare eye inflammation in children, representing 5–10% of all uveitis cases in the U.S., while HS affects approximately 1–4% of the U.S. population [3] , [4]Celltrion strengthens and expands its biosimilars immunology portfolio in the U.S., advancing affordable treatment options for patients living with chronic immune-mediated diseases INCHEON, South Korea, Oct. 17, 2025 - Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA® (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.[1],[2] The FDA previously approved YUFLYMA as a biosimilar to Humira® for a variety of indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps). HS and UV were previously approved in adult patients, and the latest approval expands these two indications to include pediatric and adolescent populations.[1] HS, which affects approximately 1%-4% of people in the U.S., is a chronic, inflammatory, recurrent skin condition characterized by painful nodules, abscesses, comedones, fistulas, sinus tracts, and scarring in intertriginous areas. Adolescent HS shares similar clinical features and often disrupts school and daily life. Pediatric UV, a potentially sight-threatening eye condition that accounts for 5-10% of all uveitis cases, is frequently asymptomatic in children and can become chronic or may have significant morbidities in pediatric patients, such as cataract, glaucoma, and amblyopia.[5],[6] "Adolescent HS and pediatric UV are chronic inflammatory conditions that can have serious sequelae and place a significant burden on patients, their families, and caregivers. It impacts patients physically and also emotionally and socially," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "With this label expansion, YUFLYMA is now able to provide treatment options for more patient populations, further supporting broader access for both patients and physicians." YUFLYLMA was first introduced in the U.S. market in July 2023 and is currently available as 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg solution for injection in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to meet differing patient needs and improve patient affordability. "The expansion of pediatric indications for YUFLYMA highlights our commitment to addressing unmet needs in both adult and pediatric immune-mediated diseases," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "The approval of pediatric indications for YUFLYMA and unbranded adalimumab-aaty strengthens our growing immunology portfolio and supports broader patient access to high-quality, affordable treatments." ### Notes to Editors:About YUFLYMA ®  (CT-P17, biosimilar adalimumab-aaty) [1] YUFLYMA® is a high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in prefilled syringe as 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL and autoinjector as 40mg/0.4mL and 80mg/0.8mL. Additionally, YUFLYMA features one of the longest shelf lives in its class, maintaining stability at room temperature (77 °F, 25 °C) for up to 31 days. IMPORTANT SAFETY INFORMATION [1] This important safety information also applies to YUFLYMA ®  (adalimumab-aaty). SERIOUS INFECTIONSPatients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections.Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy.In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients.NMSC was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of psoralen + ultraviolet light A (PUVA) treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty.In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers.Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITYAnaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATIONUse of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONSUse of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop.There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONSRare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents.Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products.Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURECases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products.Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITYTreatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONSPatients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines.It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy.No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products.The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONSThe most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for:Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RAJuvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and olderPsoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsAAnkylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ASCrohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and olderUlcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockersPlaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriateHidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and olderUveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult and pediatric patients 2 years of age and older For Yuflyma (adalimumab-aaty):  Please click for Full U.S. Prescribing Information. For adalimumab-aaty: Please see Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology,  endocrinology and ophthalmology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media - LinkedIn. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipates", the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. TrademarksHumira is a registered trademark of AbbVie.YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References[1] Yuflyma U.S. prescribing information (2025)[2] Adalimumab-aaty U.S. prescribing information (2025)[3] Tuğal-Tutkun İ. An Overview of Pediatric Uveitis. Turk Arch Pediatr. 2023 Jul;58(4):363-370. doi:10.5152/TurkArchPediatr.2023.23086. PMID: 37357450; PMCID: PMC10441137.[4] U.S. Food & Drug Administration. Hidradenitis Suppurativa. Available at: https://www.fda.gov/consumers/health-education-resources/hidradenitis-suppurativa[5] Nives Pustisek et al., Hidradenitis suppurativa in children and adolescents, Clinics in Dermatology, Volume 43, Issue 4, 2025, Pages 455-461, ISSN 0738-081X, https://doi.org/10.1016/j.clindermatol.2025.05.005. Available at:https://www.sciencedirect.com/science/article/pii/S0738081X25001476 [6] Arash Maleki et al., Pediatric uveitis: A comprehensive review, Survey of Ophthalmology, Volume 67, Issue 2, 2022, Pages 510-529, ISSN 0039-6257, https://doi.org/10.1016/j.survophthal.2021.06.006. Available at: https://www.sciencedirect.com/science/article/pii/S0039625721001430 

2025
10
17
Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)

  EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR) Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions INCHEON, South Korea, Oct. 9, 2025 - Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).[1] Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in ocular angiogenesis. "Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have EYDENZELT approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the U.S.," said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. "With EYDENZELT demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases—helping physicians broaden their options and improving patient outcomes." The FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomized, double-masked, parallel-group, multicenter phase III study of EYDENZELT, the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT was compared to EYLEA in patients with diabetic macular edema (DME). The 52-week trial included 348 patients with DME. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing EYDENZELT and EYLEA. Results of the study showed that EYDENZELT met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to EYLEA. "Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world and nearly 20 million people in the U.S. are living with some form of age-related macular degeneration," said Dr. David M. Brown, Director, Retina Consultants of Texas Research Centers, Co-chair, Medical Leadership Board Retina Consultants of America. "EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases." EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology. EYDENZELT was also approved by the European Commission (EC) in February 2025.   ### About EYDENZELT® ( aflibercept-boav ) EYDENZELT® (aflibercept-boav) is a vascular endothelial growth factor (VEGF) inhibitor referencing EYLEA® (aflibercept). EYDENZELT is approved based on a comprehensive data confirming the therapeutic equivalence EYLEA. In the U.S., EYDENZELT is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). INDICATIONSEYDENZELT® (aflibercept-boav) is indicated for the treatment of patients with:Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Diabetic Macular Edema (DME)Diabetic Retinopathy (DR) IMPORTANT SAFETY INFORMATIONEYDENZELT is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and hypersensitivity to aflibercept or any of the excipients in EYDENZELT.Instruct patients and/or caregivers to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. For more information, see Full Prescribing Information . About Celltrion , Inc.Celltrion, Inc. is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has ten biosimilar products approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com, and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. TrademarksEYDENZELT® is a registered trademark of Celltrion, Inc.EYLEA® is a registered trademark of Regeneron Pharmaceuticals Inc. References[1] EYDENZELT U.S. prescribing information (2025) US--24-00028

2025
10
10
Celltrion Presents Positive Real-World Data on Switching from intravenous (IV) to subcutaneous (SC) infliximab at UEG Week 2025 Meet the Expert sessions

Switching from intravenous (IV) to subcutaneous (SC) infliximab was shown to be well tolerated, with a low relapse risk for most IBD patients and high treatment persistence1, 2 INCHEON, South Korea – Celltrion, Inc. today showcased real-world evidence supporting the use of subcutaneous (SC) infliximab, confirming the efficacy and safety of switching to SC infliximab 120mg every two weeks in patients with inflammatory bowel disease (IBD). The real-world evidence was presented at the Meet the Expert (MTE) Sessions at UEG 2025, and included presentations from Professor Nicolas Mathieu, Medical Director of MICI Institut Privé, Cliniques des Cèdres and Associate Professor of Gastroenterology, and Prof Anthony Buisson, Head of IBD Unit at University Hospital Estaing, Clermont Ferrand, France. Professor Nicolas Mathieu presented a real-life study which demonstrated that the switch from IV infliximab to SC infliximab is well tolerated amongst patients. The presentation particularly highlighted the results from the multicentric, prospective PEREM real-life cohort study, which found high treatment persistence, with more than 95% of patients in remission remaining on therapy after one year in real-world practice.1 In addition, there was no significant difference of SC infliximab persistence at Week 48 between patients who were on combination therapy with immunomodulator at both inclusion and 3 months and those on SC infliximab monotherapy.2 In Professor Anthony Buisson’s session, it was shared that patients switching from IV to SC infliximab is feasible and safe, even in challenging cases such as obesity, prior perianal disease, or patients with complicated phenotypes (structuring or fistulizing CD). Long term persistence of SC infliximab was also confirmed in multiple studies across the UK and France, and was generally considered effective, safe, and well accepted, with low relapse risk in most IBD patients. SC infliximab also showed promising efficacy after IV induction in patients with active perianal lesions.1 “The Meet the Expert sessions provide an important opportunity to share real-world evidence on the role of subcutaneous infliximab,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The evidence confirms that switching from intravenous to subcutaneous therapy is effective and safe and supports more sustainable healthcare delivery.” Notes to Editors: About the subcutaneous (SC) formulation of CT-P13CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.3,4 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-IV induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.5 Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.6 About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. References1 Buisson A et al. Clinical Gastroenterology and Hepatology 2023; Buisson A et al. Alimentary Pharmacology and Therapeutics 20232 Mathieu N et al., Persistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission. Clinical Gastroenterology and Hepatology. 20253 Schreiber S et al., Gastroenterology. 2021;160(7):2340-23534 Westhovens R et al., Rheumatology. 2021;60(5):2277-22875 European Medicines Agency Summary of Product Characteristics (SmPC), Remsima®. Available at link to SmPC [Last accessed October 2025].6 Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060

2025
10
06
Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States

The AVTOZMA ® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the FDA to treat the same conditions as the reference product ACTEMRA ® (tocilizumab)AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDAThis launch strengthens Celltrion's immunology portfolio beyond tumor-necrosis factor (TNF)-alpha and interleukin (IL)-12 and 23 inhibitors, to include an IL-6 inhibitor , broadening coverage across multiple inflammatory pathways and addressing a wider spectrum of diseases and patient populations INCHEON, South Korea, Oct. 2, 2025  -- Celltrion, Inc. today announced that AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation is now available to patients in the United States. AVTOZMA IV is approved for all same indications as the reference product Actemra®  (tocilizumab), including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), coronavirus disease (COVID-19) and cytokine release syndrome (CRS).[1] AVTOZMA IV will be available in all the same formulations currently provided by ACTEMRA IV. The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials. "Immune-mediated conditions such as rheumatoid arthritis have profound impact on patients' daily lives," said Prof. Gerd-Rüdiger Burmester, MD, Professor of Medicine and Rheumatology, Senior Professor in the Department of Rheumatology and Clinical Immunology at Charité - Universitätsmedizin Berlin, Germany. "The availability of a tocilizumab biosimilar gives physicians additional options to manage the disease and maintain continuity of care, which is a welcome news for both patients and clinicians." "The launch of AVTOZMA IV reinforces Celltrion's strong commitment to providing physicians and patients with access to high-quality treatment options for serious immune-mediated diseases and to supporting the sustainability of the U.S. healthcare system," said Thomas Nusbickel, Chief Commercial Officer of Celltrion USA. "It also strengthens our immunology portfolio, expanding beyond TNF-α and IL-12/23 inhibitors, now including an IL-6 inhibitor, broadening coverage across inflammatory pathways and enhancing our ability to address a broader range of patient needs." At launch, AVTOZMA IV will be supported by a comprehensive patient support resources for healthcare providers and patients, and copay support for eligible commercial patients prescribed AVTOZMA IV. Notes to Editors: About AVTOZMA ®  (CT-P47, tocilizumab-anoh)AVTOZMA® (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, AVTOZMA received approval from the U.S. Food and Drug Administration (FDA) and European Commission (EC) in January and February 2025, respectively. In July 2025, the FDA approved an additional indication for the intravenous (IV) formulation of AVTOZMA for the treatment of cytokine release syndrome (CRS) in adult and pediatric patients aged two years and older.  INDICATION AVTOZMA® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).Giant Cell Arteritis (GCA): Adult patients with GCA.Polyarticular Juvenile Idiopathic Arthritis (pJIA): Patients 2+ years-old with active pJIA.Systemic Juvenile Idiopathic Arthritis (sJIA): Patients 2+ years-old with active sJIA.Cytokine Release Syndrome (CRS): Adults and pediatric patients 2+ years-old with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndromeCOVID-19: Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS INFECTIONSAVTOZMA ® and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants.If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include:Active tuberculosis (TB) which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during treatment (except in COVID-19 patients) and treat latent infections before starting AVTOZMA.Invasive fungal infections: Such as candidiasis, aspergillosis, and pneumocystis, may present as disseminated rather than localized disease.Opportunistic infections, including bacterial, viral and other opportunistic pathogens. Monitor patients for signs of infection, including TB, during and after AVTOZMA treatment.Contraindications: Known hypersensitivity to tocilizumab products.Serious Infections. Serious and sometimes fatal infections have been reported with AVTOZMA. Do not use during active infections, including localized infections. Discontinue AVTOZMA if a serious infection occurs and resume only once controlled.Gastrointestinal (GI) Perforation. Gastrointestinal perforations, often linked to diverticulitis, have been reported with tocilizumab. Use AVTOZMA cautiously in high-risk patients and promptly evaluate new abdominal symptoms for early detection and management.Hepatotoxicity . Monitor for hepatic injury signs. Avoid AVTOZMA if ALT/ AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19); discontinue if ALT/AST >5x ULN or symptoms of liver disease develop.Changes in Laboratory Parameters. Monitor neutrophils, platelets, liver enzymes, and lipids due to potential treatment-related changes; avoid initiating AVTOZMA in patients with critically low ANC or platelet counts.Immunosuppression. The impact of AVTOZMA on malignancy development is unknown, but it may increase risk as an immunosuppressant.Hypersensitivity Reactions, including anaphylaxis, and death, have occurred; administer IV infusions with anaphylaxis management support, discontinue permanently if reactions occur, and avoid use in patients with known hypersensitivity.Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases were reported; monitor symptoms and use caution with preexisting or recent disorders.Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.Live Vaccines. Avoid concurrent use with AVTOZMA.Adverse Reactions (≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated ALT, and injection site reactions. For more information, see Full  Prescribing Information . About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USACelltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media - LinkedIn. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipates", the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. TrademarksAVTOZMA® is a registered trademark of Celltrion Inc.ACTEMRA® is a registered trademark of Chugai Pharmaceutical Co., Ltd.  References[1] AVTOZMA U.S. prescribing information (2025)

2025
10
03
Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 2025

Celltrion’s Omlyclo™, the first and only omalizumab biosimilar in Europe, will be commercially available starting in Norway, with subsequent rollouts in European countriesResults from the global Phase III clinical trial of Omlyclo™ (CT-P39) for the treatment of chronic spontaneous urticaria (CSU), allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) will be presented at a satellite symposium during the 2025 European Academy of Dermatology and Venereology (EADV) CongressCelltrion highlights the strength of its expanding dermatology portfolio with positive clinical results for CT-P55, a biosimilar candidate referencing secukinumabWith the launch of Omlyclo™, Celltrion underscores its commitment to advancing innovative and accessible treatments in immunology and dermatology INCHEON, South Korea--(BUSINESS WIRE)--Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereology (EADV) Congress, held 17-20 September in Paris, France. Following the European Commission (EC) approval of Omlyclo™, the first and only omalizumab biosimilar in Europe in May 2024, Omlyclo™ will be commercially available starting in Norway, with subsequent rollouts in European countries. As part of Celltrion’s mission to advance knowledge and understanding in dermatology, especially in chronic spontaneous urticaria (CSU), the company hosted satellite symposium presenting the results of the global Phase III clinical trial of Omlyclo™. The global Phase III clinical trial involved 619 patients with CSU, following them up to week 40. Patients were randomized to receive 300 mg or 150 mg of Omlyclo™, or reference product, every 4 weeks. Starting from week 12, patients who received Omlyclo™ were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomized in a 1:1 ratio to either switch to Omlyclo™ or to continue receiving the reference product. From week 24 until week 40, patients were observed without dosing. The results demonstrated that Omlyclo™ had comparable efficacy and safety to reference product during both treatment and off-dose periods.1,2 “Immuno-dermatology diseases such as CSU significantly impact a patient's quality of life (QoL), affecting various aspects including mental and emotional well-being, social life, daily activities, and even financial stability,” said Prof. Martin Metz, MD, Deputy Director of the Institute of Allergology, Charité- Universitätsmedizin Berlin, Germany. “Availability of an omalizumab biosimilar in the EU is both timely and significant, offering a much-needed option for patients and healthcare providers. The clinical trial of Omlyclo™ clearly met the safety and efficacy endpoints, thereby offering a tangible promise for all eligible patients.” “At this year’s EADV Congress, Celltrion reinforced dermatologists’ confidence in Omlyclo™, the first and only omalizumab biosimilar in Europe, by presenting robust clinical evidence supporting its biosimilarity and assuring physicians that switching from the original product to Omlyclo™ is safe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “As a biosimilar-focused company, we remain committed to building long-term trust with healthcare professionals and strengthening our presence in the European market.” To further its commitment to immunology, Celltrion presented an abstract for its proposed secukinumab biosimilar candidate, CT-P55 which demonstrated comparable efficacy and safety profiles to the reference secukinumab in healthy subjects.3 With the launch of Omlyclo™, Celltrion's dermatology portfolio now comprises five products: Remsima™ (infliximab), Remsima™ SC (subcutaneous infliximab), Yuflyma™ (adalimumab), SteQeyma™ (ustekinumab), and Omlyclo™ (omalizumab), further strengthening the company’s presence in the treatment of immune-mediated skin conditions. Celltrion plans to continue solidifying its position in dermatology by advancing biosimilar candidates, including CT-P55, and expanding its post-commercialization activities within the therapeutic area. Notes to Editors: About Omlyclo™ (omalizumab)Omlyclo™ is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In the EU, Omlyclo™ is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). About CT-P55 (biosimilar candidate of secukinumab)CT-P55 is a proposed biosimilar of reference secukinumab developed by Celltrion, Inc. Secukinumab is a human monoclonal antibody that selectively targets interleukin-17A and has been demonstrated to be highly efficacious in the treatment of moderate to severe plaque psoriasis, starting at early time points, with a sustained effect and a favorable safety profile.4 CT-P55 is currently undergoing global Phase III clinical trials. About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. TrademarkXolair® is a registered trademark of Novartis AG. References1 Sarbjit Singh Saini et al., CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. Available at: https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.16446?msockid=30d535870b30638b14c920090a18627c [Last accessed August 2025]2 Grattan C et al., Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study. Clin Transl Allergy. 2025 Jun;15(6):e70069.3 Hasunuma et al., Pharmacokinetics, Safety and Immunogenicity comparision of Secukinumab Biosimilar (CT-P55) with Reference Secukinumab in Healthy male Subjects. E-poster presentation (abstract no. 122) Presented at EADV 2025.4 Karle et al., Secukinumab, a novel anti-IL-17A antibody, shows low immunogenicity potential in human in vitro assays comparable to other marketed biotherapeutics with low clinical immunogenicity. mAbs. 2016;8(3):536-50. doi:10.1080/19420862.2015.1136761

2025
09
19
Letter to Shareholders [Notice Regarding the Acquisition of Eli Lilly’ U.S. Manufacturing Facility]

Dear Shareholders, On July 29, we informed you that we had been selected as the preferred bidder for the acquisition of a biologics manufacturing facility in the United States. As of September 20 (local time), we have successfully signed an agreement with Eli Lilly to acquire this facility. We are pleased to share the details with you promptly, as outlined below. 1. Overview of the AcquisitionFacility to be Acquired: A biopharmaceutical drug substance (DS) plant in Branchburg, New Jersey, owned by global pharmaceutical leader Eli Lilly. The site covers approximately 37 acres, including four buildings (with 10 acres of vacant land available for future use)Acquisition Value: Approximately KRW 460 billion (about KRW 700 billion including operational funds)Acquiring Entity: Celltrion U.S. subsidiary (chosen for operational efficiency and legal stability) 2. Completion of Comprehensive U.S. Tariff Response PlanRecently Celltrion has proactively addressed tariff-related risks by transferring two years’ worth of inventory to the U.S. and expanding contracts with local CMO partners, implementing stage-specific measures to mitigate exposureFollowing validation of the newly acquired facility (estimated 12–18 months), Celltrion products will be manufactured and supplied directly from this siteWith this acquisition, Celltrion has fundamentally and fully eliminated all potential future tariff risks related to its products in the U.S. market 3. Additional Benefits of the AcquisitionImmediate Utilization: By acquiring an existing facility rather than constructing a new one, Celltrion achieves significant cost savings and can commence operations immediately. Full employee retention ensures continuity of production and access to skilled expertise, while ongoing CMO contracts provide immediate revenue streams and accelerate recovery of invested capital Reduction in External CMO and Logistics Costs: The facility enables full-cycle integration — from drug substance production through finished product manufacturing, packaging, logistics, and sales — within the U.S., thereby strengthening operational capacity. Localized production will also reduce logistics costs previously incurred for U.S.-bound shipments, as well as lower external CMO-related expenses 4. Next StepsPreparations are underway to transfer operations and complete closing procedures by year-endDuring this period, Celltrion will proceed with required regulatory approvals, including U.S. merger control filings, and expects to finalize the transaction by the end of this year As the acquisition process moves forward, we remain committed to keeping our shareholders fully informed of any updates in a timely manner, ensuring continued trust and support for Celltrion.  Thank you.

2025
09
23
Letter to Shareholders [Explanation and Company Position on the Trump Administration’s Letter Regarding Drug Price Reductions]

Dear Shareholders,On July 31, 2025 (local time), U.S. President Donald Trump sent a letter to 17 global pharmaceutical companies, calling on them to reduce drug prices.This follows the executive order on lowering drug costs signed in May, and outlines several measures to be implemented within 60 days, including: ▲Applying Most Favored Nation (MFN) pricing to Medicaid ▲Guaranteeing MFN pricing for newly launched drugs ▲Redirecting a portion of international profits to benefit U.S. patients and taxpayers ▲Allowing direct-to-patient sales based on MFN pricing.As previously explained in our May 21 website announcement, this initiative appears to be primarily targeted at high-cost drugs that impose a burden on U.S. patients. Since Celltrion already supplies products at competitive prices and promotes price competition through biosimilars, we do not expect our products to be directly affected.Moreover, if the MFN pricing policy leads to reduced prices for expensive originator drugs, the current environment—where originals are prioritized in formularies—is expected to shift toward more direct competition with biosimilars, thereby expanding prescription opportunities for our biosimilar portfolio.In addition, the company has completed mid- to short-term countermeasures related to U.S. pharmaceutical tariff policies, including securing a two-year supply of inventory locally and finalizing agreements with local CMO partners to expand production within the U.S. At the same time, the company has been selected as the preferred bidder for the acquisition of a biologics manufacturing plant in the U.S., preparing a fundamental solution that can comprehensively resolve all potential tariff risks going forward.We remain committed to closely monitoring changes in global healthcare policy, including in the United States, and will continue to share relevant developments with our shareholders promptly to ensure continued trust and support.Thank you.

2025
08
01
Letter to Shareholders [Company Statement Regarding U.S. Tariff Response Strategy]

Dear Shareholders, Our company has been closely monitoring the evolving U.S. pharmaceutical tariff policies and has proactively developed phased strategies to minimize their impact. With the recent designation of a preferred bidder for the acquisition of a biologics manufacturing plant in the United States—a fundamental solution to the tariff issue—we are pleased to promptly share the latest developments with our valued shareholders as follows:  1. Comprehensive Update on U.S. Tariff Response StrategyShort-term Response: Completed stockpiling of two years’ worth of inventory within the U.S.Mid-term Response: Expand contracts with local CMO companies to enable domestic production in the U.S. for products sold in the U.SLong-term Response: Designated as the preferred negotiating party for the acquisition of a biologics manufacturing plant in the U.S. Upon completion of the acquisition, this will serve as a fundamental solution capable of fully mitigating all future tariff-related risks. 2. Details on the Facility Acquisition in the U.S.1) OverviewThe facility Celltrion is pursuing is a large-scale cGMP manufacturing plant in the U.S capable of producing drug substances (DS), currently owned by an undisclosed global pharmaceutical company. The plant is located within a major pharmaceutical cluster that has been manufacturing key biologics—such as cancer and autoimmune disease treatments—for several years.Further details, including the name of the company that currently owns the acquired facility, will remain undisclosed until the signing of the final agreement, which is expected to take place in early October, in accordance with mutual agreement. 2) Expected BenefitsResolution of Tariff Risk: Upon completion of the acquisition, the facility is expected to eliminate all future tariff-related risks for our pharmaceutical products. This involves completing the acquisition of a local manufacturing facility, which represents a fundamental solution to the tariff issue. By producing our core products sold in the U.S. directly on-site, we expect to completely eliminate the tariff risks associated with these products. Capacity Expansion Through Facility Growth: We plan to initiate additional facility expansions in line with U.S. sales trends and product launch schedules. Once completed, production capacity is expected to increase by up to 1.5 times that of our Songdo Plant 2. This will not only strengthen our market responsiveness but also ensure that future product launches in the U.S. fall outside the scope of tariff impacts from the outset. Immediate Revenue Generation Post-Acquisition: Approximately 50% of the facility’s capacity is currently under a CMO contract that grants exclusive rights to manufacture the seller’s biologics for five years. This will enable Celltrion to generate revenue immediately upon acquisition. We expect a swift return on investment as a result. The remaining 50% of capacity will be allocated to producing Celltrion’s major products currently sold in the U.S. Enhanced Cost Competitiveness: Once the planned expansions are completed, the local facility will be capable of handling the entire production cycle—from drug substance (DS) and drug product (DP) manufacturing to packaging and distribution—for pharmaceuticals supplied in the U.S. With our U.S. sales network already in place, we expect to see substantial cost efficiencies from in-house manufacturing and logistics savings, thereby enhancing our overall cost competitiveness. Synergies Through Advanced Technology Adoption: With the acquisition of this plant, we plan to significantly strengthen our local research and development (R&D) capabilities in the U.S. Through this, we intend to actively introduce advanced technologies from the U.S. and other global markets to maximize synergies with our production base. As a company that has grown together with our shareholders, we are committed to conducting a thorough due diligence process on the local manufacturing facility as quickly as possible to eliminate tariff-related risks at the root and enhance corporate and shareholder value. Furthermore, we will promptly share all updates related to the company’s key business matters, including the progress of the due diligence process, and strive to repay our shareholders’ continued trust and support. Thank you.

2025
07
29
[Letter to Shareholders] Company Statement Regarding the Trump Administration’s Plan to Impose Tariffs on Pharmaceuticals

Dear Shareholders, On July 9, 2025 (Korea Standard Time), U.S. President Donald Trump stated that his administration is considering imposing tariffs on pharmaceuticals, with a grace period of up to 18 months. Our company has been continuously monitoring developments regarding the potential imposition of U.S. pharmaceutical tariffs and has prepared response strategies for various scenarios to minimize potential impact. As previously announced, the key points of our response strategy are as follows:  Short-term: We have already secured a two-year inventory supply and plan to maintain this two-year inventory on a rolling basis going forward. Mid-term: We have finalized contracts with local CMO (Contract Manufacturing Organization) partners to enable local production of products sold in the U.S. Long-term: We are currently reviewing the acquisition of a company with manufacturing facilities in the U.S., and we will promptly provide further details to our shareholders once the matter becomes more concrete.  As shared during the investor day in May, we are systematically implementing our response plan not only for the short term but also for the mid to long term. Regardless of when or to what extent the U.S. pharmaceutical tariff policy is finalized, our goal is to have all necessary preparations in place by the end of next year to ensure minimal impact on our business. We will continue to keep our shareholders informed of all relevant developments and strive to maintain your trust and support for the company. Thank you. 

2025
07
09